DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election without traverse of Group/Invention I – claims 1-16 (drawn to a porous, implantable structure) in the reply filed on 18 November 2025 is acknowledged.
3. Applicant’s election without traverse of NON-POLYGONAL SHAPE OF PORE – Species A (embodied in Figure 2A) in the reply filed on 18 November 2025 is acknowledged. According to Applicant’s response, claims 1-11 read on the elected embodiment. Notice, claims 12-16 have been canceled in the response filed 18 November 2025.
4. Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 November 2025.
Claim Rejections - 35 USC § 102
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
6. Claims 1, 2, 4-7, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Sharp et al. (US PG Pub No. 2017/0056178 A1).
Regarding independent claim 1 and independent claim 10, and referring to Figures 37B, 53A-53D, 54A-54E, 55A-55E, 56A, 56B, 57A, and 57B, Sharp et al. ‘178 disclose a porous (Abstract), implantable (Abstract) structure, comprising:
substantially regularly arranged elementary cells (Figures 53A-53D and 54A-54E – cells 5300; Figures 55A-55E, 56A, 56B, 57A, and 57B – cells 5500), wherein the elementary cells comprise interior spaces (clearly shown in Figures 37B, 53A-53D, 54A-54E, 55A-55E, 56A, 56B, 57A, and 57B) that form a plurality of interconnected pores (fenestrations; see, e.g., [0116]), the elementary cells comprise basic elements (Figures 53A-53D and 54A-54E – struts 5302a, 5302b; Figures 55A-55E, 56A, 56B, 57A, and 57B – struts 5502a, 5502b) arranged in layers (Figures 54D and 54E – each figure clearly shows at least a top layer and a bottom layer, wherein each layer is comprised of basic elements; Figures 56A and 56B – at least two layers 5602 layer, wherein each layer is comprised of basic elements; Figures 57A and 57B – at least two layers 5702 layer, wherein each layer is comprised of basic elements), wherein the basic elements are configured to form a non-polygonal shape (e.g., circular) of each of the plurality of interconnected pores (clearly shown in Figures 37B, 53A-53D, 54A-54E, 55A-55E, 56A, 56B, 57A, and 57B; further, see paragraph [0116]), wherein each layer is offset with respect to an adjacent layer (Figures 54D and 54E – the pores/fenestrations of the top layer are offset from the pores/fenestrations of bottom layer, and therefore a layer is at least offset in relation to the other layer in at least in one plane; Figures 56A and 56B – the top layer 5602 is clearly shown as offset from bottom layer 5602; Figures 57A and 57B – the top layer 5702 is clearly shown as offset from bottom layer 5702; further, see [0119]).
Regarding claim 2, Sharp et al. ‘178 teaches wherein the basic elements comprise a biocompatible material (Abstract; [0021]; [0033]).
Regarding claim 4, Sharp et al. ‘178 teaches wherein the basic elements are made in place through deposition and solidification ([0007]; [0021]; [0086]; [0123]; [0124]).
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 5, Sharp et al. ‘178 teaches wherein the basic elements are formed by an Electron Beam Melting (EBM) process and/or a Selective Laser Melting (SLM) process ([0086]; [0124]).
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 6, Sharp et al. ‘178 teaches wherein the interconnected pores comprise a pore width, wherein the pore width is between about 0.1 mm to about 1.5 mm ([0116]). Notice, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 7, Sharp et al. ‘178 teaches wherein the interconnected pores comprise a pore width, wherein the pore width is between about 0.4 mm to about 1.0 mm ([0116]). Notice, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding independent claim 10, Sharp et al. ‘178 teaches an endoprosthetic implant ([0002]; [0007]; [0012]; [0032]; [0121]) comprising a body made of a solid material and a bone contacting portion made of a porous, implantable structure (the “a bone contacting portion made of a porous, implantable structure” is explained above, in the rejection of independent claim 1). Notice, the “a solid material” is broadly interpreted to read on any portion of the implant not constructed as a “porous, implantable structure” (e.g., [0032] – “the porous structure forms at least a portion of a medical implant, such as an orthopedic implant, dental implant or vascular implant”).
Regarding claim 11, Sharp et al. ‘178 teaches wherein the body is a component of an articulated joint ([0002]; [0007]; [0012]; [0032]; [0121]).
Claim Rejections - 35 USC § 103
7. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sharp et al. (US PG Pub No. 2017/0056178 A1) in view of Bauer (US PG Pub No. 2018/0193152 A1).
Regarding claim 3, Sharp et al. ‘178 discloses the invention as claimed, except for particularly disclosing wherein at least a portion of the structure is coated with a bone growth promoting material. However, this is already known in the art. For example, Bauer ‘152 teaches a porous, implantable structure (Figures 1, 2, 3A-3D, 4, 12, 13) wherein at least a portion of the structure is coated with a bone growth promoting material ([0028] – “this does not preclude the option of providing at least a portion of the elementary cells with a coating of bone growth promoting material, in particular calcium phosphate (CaP)”; further, see [0063]) in order to achieve a more rapid and thorough ingrowth of adjacent natural bone material into the bone augment ([0028]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein at least a portion of the structure is coated with a bone growth promoting material, as taught by Bauer ‘152, with the invention of Sharp et al. ‘178, in order to achieve a more rapid and thorough ingrowth of adjacent natural bone material into the bone augment.
9. Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sharp et al. (US PG Pub No. 2017/0056178 A1) in view of Bauer (US PG Pub No. 2018/0193152 A1).
Regarding claim 8 and claim 9, Sharp et al. ‘178 discloses the invention as claimed, except for particularly disclosing wherein a thickness of the basic elements is between about 0.2 mm to about 1.0 mm. However, this is already known in the art. For example, Bauer ‘152 teaches a porous, implantable structure (Figures 1, 2, 3A-3D, 4, 12, 13) wherein a thickness of the basic elements is between about 0.2 mm to about 1.0 mm ([0034] – “the legs of the tetrapods defining walls of the pores having a thickness between 0.2 and 1.0 mm, preferably between 0.4 and 0.7 mm”) or wherein a thickness of the basic elements is between about 0.4 mm to about 0.7 mm ([0034] – “the legs of the tetrapods defining walls of the pores having a thickness between 0.2 and 1.0 mm, preferably between 0.4 and 0.7 mm”), which features improve mechanical characteristics, leading to improved biocompatibility (Abstract). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein a thickness of the basic elements is between about 0.2 mm to about 1.0 mm, or wherein a thickness of the basic elements is between about 0.4 mm to about 0.7 mm, as taught by Bauer ‘152, with the invention of Sharp et al. ‘178, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774